COVID-19NCT04832919
A Nurse-Community Health Worker-Family Partnership Model: Addressing Uptake of COVID-19 Testing and Control Measures
A study testing Nurse-Community-Family Partnership Intervention in people with COVID-19, run by New York University at 1 site in United States.
Trial summary
Historically, health disparities in the US are concentrated among underserved communities and socially vulnerable populations. The disproportionate COVID-19 related morbidity and mortality in communities of color and socioeconomic disadvantage acutely highlight this persistent public health problem, drawing attention… Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Nurse-Community-Family Partnership Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2021to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Residence in one of the public housing complexes in Mott Haven, South Bronx
- English or Spanish-speaking
- Age 10 years or older
- Willing and able to provide informed consent or assent
Who cannot join
- Non-resident of one of the public housing complexes in Mott Haven, South Bronx
- Neither English nor Spanish speaker
- Younger than 10 years old, unless household index case tests antigen positive. In this instance, all members of family will be included.
- Unwilling or unable to provide informed consent or assent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Nurse-Community Health Worker-Family Partnership Model to Increase COVID19 Testing in Urban Underserved and Vulnerable Communities
Historically, health disparities in the US are concentrated among underserved communities and socially vulnerable populations. The disproportionate COVID-19 related morbidity and mortality in communities of color and socioeconomic disadvantage acutely highlight this persistent public health problem, drawing attention to the urgent need for more equitable reach of testing, prevention, and control measures. The proposed research addresses this need using a 2-arm randomized controlled trial (RCT) that will evaluate the effectiveness of the Nurse-Community Health Worker (CHW)-Family Partnership intervention in promoting COVID-19 testing uptake, adoption of COVID control measures, and mutual aid capacity at the household level in an underserved and vulnerable population disproportionately affected by COVID-19. Enrolled households will be randomly assigned to either the intervention group where families will receive the Nurse-CHW-Family Partnership intervention including the offer of in-home testing and referral to seasonal influenza vaccination services, or the treatment-as-usual control group, which will be used to measure actual testing rates among public housing residents in relation to participant and household characteristics. The study hypothesis is that the Nurse-CHW-Family Partnership intervention will improve household-level COVID-19 testing uptake, adoption of COVID control measures, and mutual aid capacity relative to the treatment-as-usual control.
Read the detailed description
The investigators will recruit and follow a randomly-chosen sample of NYCHA public housing residents in the proposed target community who meet multiple criteria for being considered vulnerable or underserved. The current study will address knowledge gaps regarding COVID-19 testing, treatment, and household prevention strategies, and generate new knowledge related to the epidemiology of COVID-19 in these communities. Working with community partners, the investigators will create an acceptable and feasible intervention and testing infrastructure in advance of the influenza season, with a view toward designing best practices for sustainable COVID-19 testing, prevention, and preparedness for vaccination trials. The investigators will implement a 2-arm RCT that will evaluate the effectiveness of the Nurse-CHW-Family Partnership Intervention in promoting COVID testing uptake, adoption of COVID control measures, and household mutual aid capacity. The investigators will recruit members of randomly selected households in their homes using area sampling methods used with excellent results in the investigators' previous research in the target community. Participants will complete a baseline assessment and the entire household will be randomized to either the experimental or a treatment-as-usual control condition, which will be used to measure actual testing rates among public housing residents in relation to participant and household characteristics. The baseline sample will include 150 households, and 400 individual household members, randomized in a 2:1 ratio, intervention:control. Families will complete follow-up assessments at 6 and 9 months following the baseline. In-home testing and referral to seasonal influenza vaccination services will be offered to the intervention group; whereas the control group will receive treatment as usual at multiple NYC Department of Health COVID-19 testing sites that are within walking distance of each of the three housing complexes. Test acceptance will be recorded, and incentives will be paid for study visits, not for testing.
- Conditions
- COVID-19
- Being tested
- Nurse-Community-Family Partnership Intervention
- Keywords
- SARS-CoV-2, COVID-19, COVID-19 testing, Behavioral COVID-19 Mitigation Measures
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Community-Family Partnership InterventionBehavioural
Nurses conduct home visits on a monthly basis for the first five months post-baseline. During visits, nurses emphasize the importance of infection control measures and, jointly with household members, develop and follow-up on the implementation of an infection control plan tailored to the unique circumstances of the household. Nurses deliver training on infection control skills necessary for optimal implementation of the plan. Nurses offer at-home SARS-CoV-2 testing to all members of the household. Nurses conduct triage, medical case management, monitoring, and follow-up of individuals identified to have COVID-19 or any other acute health emergencies. CHWs conduct visits on a bi-weekly basis for the first five months post-baseline. CHWs deliver healthcare information and medical mistrust counseling in a culturally relevant and linguistically appropriate fashion; and provide social support, navigate household members to social welfare/vocational/economic/psychosocial services.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-Community Health Worker-Family Partnership | Experimental | The experimental arm will receive the Nurse-Community Health Worker-Family Partnership intervention Receives: Behavioral: Nurse-Community-Family Partnership Intervention |
| Standard of Care | No intervention | The control arm will receive standard access to NYC Department of Health COVID-19 testing sites and standard COVID-19 public health messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Household COVID-19 Testing Uptake
All medical services delivered by nurses during home-visits (such as COVID-19 test administration) will be carefully documented by the investigative team. At the time of the assessment, the investigators will obtain self-reported information regarding COVID-19 testing uptake by study participants in the treatment and control groups. Respondents will be asked whether they have received COVID-19 testing in the past three months [Yes/No].
Measured: Delayed Follow-Up (9 Months)
COVID-19 Symptoms, Diagnoses, and Testing Scale
An adapted version of the (PhenX Toolkit) COVID-19 Symptoms, Diagnoses, and Testing Scale will be used to measure COVID-19 symptoms, diagnoses, and testing. Participants will be asked questions regarding whether they are currently sick with an illness that might be related to COVID-19, any symptoms the participant experienced in the past three months [Check All That Apply], and the result of the participant's last COVID-19 test [Positive/Negative].
Measured: Delayed Follow-Up (9 Months)
Secondary outcomes (10)
COVID-19 Avoidant Behaviors Scale
An adapted version of the COVID-19 Avoidant Behaviors Scale (PhenX Toolkit) will be used to measure the secondary study outcome of COVID-19 control measure uptake. Respondents will be asked questions regarding their engagement in behaviors associated with COVID-19 exposure on a 5-point scale [Almost Never, Sometimes, a Moderate Amount of the Time, Most of the Time, Always]; with greater values indicating higher frequency of uptake of COVID-19 prevention behaviors in the past three months (e.g., "Had close contact (within 6 feet) with people who do not live with you. "Gone out to a bar, club, or other place where people gather) and questions regarding their uptake of COVID-19 control (e.g., "Worn a mask or other face covering." "Washed your hands with soap or used hand sanitizer several times per day").
Measured: Delayed Follow-Up (9 Months)
Vaccine Uptake
Referral to COVID-19 and seasonal influenza vaccination services by study nurses to intervention group participants will be carefully documented by the investigative team. At the time of the delayed assessment, the investigators will obtain self-reported information and documentation of COVID-19 and influenza vaccine uptake by study participants in the treatment as usual control group. For self-reported information, respondents will be asked if they received the flu shot in the past three months [Yes/No] and whether they received the COVID-19 vaccine [Yes/No], the type of vaccine, and the number of doses.
Measured: Delayed follow up (9 months)
COVID-19 Improved Household & Family Mutual Aid
A set of measures will assess families' abilities to adjust to the COVID-19 pandemic, as evidenced by the reported overall impact of COVID-19 on family dynamics and relationships, psychological distress, food and housing insecurity, substance use, and sexual behavior in the past three months.
Measured: Delayed follow up (9 months)
COVID-19 Household Environment Scale
An adapted version of the COVID-19 Household Environment Scale will be used to measure the secondary study outcome household/family mutual aid. The scale measures household conflict/togetherness. Participants are asked to rate, on a 5-point Likert scale, how much more or less conflict there was (as compared to before COVID-19) about 15 topics in the past three months (e.g., "Home maintenance;" "Decisions about visitors to the home"), with higher values indicating greater frequency of family conflict concerning the topic.
Measured: Delayed follow up (9 months)
Household COVID-19 Testing Uptake
All medical services delivered by nurses during home-visits (such as COVID-19 test administration) will be carefully documented by the investigative team. At the time of the assessment, the investigators will obtain self-reported information regarding COVID-19 testing uptake by study participants in the treatment and control groups. Respondents will be asked whether they have received COVID-19 testing in the past six months [Yes/No].
Measured: Immediate follow up (6 months)
COVID-19 Symptoms, Diagnoses, and Testing Scale
An adapted version of the (PhenX Toolkit) COVID-19 Symptoms, Diagnoses, and Testing Scale will be used to measure COVID-19 symptoms, diagnoses, and testing. Participants will be asked questions regarding whether they are currently sick with an illness that might be related to COVID-19, any symptoms the participant experienced in the past six months [Check All That Apply], and the result of the participant's last COVID-19 test [Positive/Negative].
Measured: Immediate follow up (6 months)
COVID-19 Avoidant Behaviors Scale
An adapted version of the COVID-19 Avoidant Behaviors Scale (PhenX Toolkit) will be used to measure the secondary study outcome of COVID-19 control measure uptake. Respondents will be asked questions regarding their engagement in behaviors associated with COVID-19 exposure on a 5-point scale [Almost Never, Sometimes, a Moderate Amount of the Time, Most of the Time, Always]; with greater values indicating higher frequency of uptake of COVID-19 prevention behaviors in the past six months (e.g., "Had close contact (within 6 feet) with people who do not live with you. "Gone out to a bar, club, or other place where people gather) and questions regarding their uptake of COVID-19 control (e.g., "Worn a mask or other face covering." "Washed your hands with soap or used hand sanitizer several times per day").
Measured: Immediate follow up (6 months)
Vaccine Uptake
Referral to COVID-19 and seasonal influenza vaccination services by study nurses to intervention group participants will be carefully documented by the investigative team. At the time of the assessment, the investigators will obtain self-reported information and documentation of COVID-19 and influenza vaccine uptake by study participants in the treatment as usual control group. For self-reported information, respondents will be asked if they received the flu shot in the past six months [Yes/No] and whether they received the COVID-19 vaccine [Yes/No], the type of vaccine, and the number of doses.
Measured: Immediate follow up (6 months)
COVID-19 Improved Household & Family Mutual Aid
A set of measures will assess families' abilities to adjust to the COVID-19 pandemic, as evidenced by the reported overall impact of COVID-19 on family dynamics and relationships, psychological distress, food and housing insecurity, substance use, and sexual behavior in the past six months.
Measured: Immediate follow up (6 months)
COVID-19 Household Environment Scale
An adapted version of the COVID-19 Household Environment Scale will be used to measure the secondary study outcome household/family mutual aid. The scale measures household conflict/togetherness. Participants are asked to rate, on a 5-point Likert scale, how much more or less conflict there was (as compared to before COVID-19) about 15 topics in the past six months (e.g., "Home maintenance;" "Decisions about visitors to the home"), with higher values indicating greater frequency of family conflict concerning the topic.
Measured: Immediate follow up (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start23 Jul 2021
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent M Guilamo-Ramos, PhD, Principal investigator, New York UniversityHolly Hagan, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832919
- Sponsor's protocol ID
- 3P30DA011041-23S1
- Status last verified
- Jul 2022
- First submitted
- 2 Apr 2021
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The project team will share all individual participant data that underlie the results reported in any future published manuscript, after deidentification (text, tables, figures, and appendices). We will make available the study protocol and statistical analysis plan. The project team will make the data available beginning 3 months and ending 5 years following article publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Investigators will be approved to conduct analyses to achieve the aims in the proposal that they submit for approval by an independent review committee. Proposals should be directed to Dr. Holly Hagan (hh50@nyu.edu). To gain access, data requesters will need to sign a data access agreement.
Publications
Guilamo-Ramos V, Benzekri A, Williams D, Thimm-Kaiser M, Wizentier MM, Goodman M, Amezquita-Castro B, Hagan H. A nurse-led clinical practice model to increase healthcare reach among underserved families during public health emergencies: A randomized controlled trial. Nurs Outlook. 2025 Nov-Dec;73(6):102591. doi: 10.1016/j.outlook.2025.102591. Epub 2025 Nov 6.
PubMed 41202466
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nurse-Community Health Worker-Family Partnership Model to Increase COVID19 Testing in Urban Underserved and Vulnerable Communities
- ClinicalTrials.gov ID
- NCT04832919
- Acronym / sponsor ID
- 3P30DA011041-23S1
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, COVID-19, COVID-19 testing, Behavioral COVID-19 Mitigation Measures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 392 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Historically, health disparities in the US are concentrated among underserved communities and socially vulnerable populations. The disproportionate COVID-19 related morbidity and mortality in communities of color and socioeconomic disadvantage acutely highlight this persistent public health problem, drawing attention to the urgent need for more equitable reach of testing, prevention, and control measures. The proposed research addresses this need using a 2-arm randomized controlled trial (RCT) that will evaluate the effectiveness of the Nurse-Community Health Worker (CHW)-Family Partnership intervention in promoting COVID-19 testing uptake, adoption of COVID control measures, and mutual aid capacity at the household level in an underserved and vulnerable population disproportionately affected by COVID-19. Enrolled households will be randomly assigned to either the intervention group where families will receive the Nurse-CHW-Family Partnership intervention including the offer of in-home testing and referral to seasonal influenza vaccination services, or the treatment-as-usual control group, which will be used to measure actual testing rates among public housing residents in relation to participant and household characteristics. The study hypothesis is that the Nurse-CHW-Family Partnership intervention will improve household-level COVID-19 testing uptake, adoption of COVID control measures, and mutual aid capacity relative to the treatment-as-usual control.
Detailed description
The investigators will recruit and follow a randomly-chosen sample of NYCHA public housing residents in the proposed target community who meet multiple criteria for being considered vulnerable or underserved. The current study will address knowledge gaps regarding COVID-19 testing, treatment, and household prevention strategies, and generate new knowledge related to the epidemiology of COVID-19 in these communities. Working with community partners, the investigators will create an acceptable and feasible intervention and testing infrastructure in advance of the influenza season, with a view toward designing best practices for sustainable COVID-19 testing, prevention, and preparedness for vaccination trials. The investigators will implement a 2-arm RCT that will evaluate the effectiveness of the Nurse-CHW-Family Partnership Intervention in promoting COVID testing uptake, adoption of COVID control measures, and household mutual aid capacity. The investigators will recruit members of randomly selected households in their homes using area sampling methods used with excellent results in the investigators' previous research in the target community. Participants will complete a baseline assessment and the entire household will be randomized to either the experimental or a treatment-as-usual control condition, which will be used to measure actual testing rates among public housing residents in relation to participant and household characteristics. The baseline sample will include 150 households, and 400 individual household members, randomized in a 2:1 ratio, intervention:control. Families will complete follow-up assessments at 6 and 9 months following the baseline. In-home testing and referral to seasonal influenza vaccination services will be offered to the intervention group; whereas the control group will receive treatment as usual at multiple NYC Department of Health COVID-19 testing sites that are within walking distance of each of the three housing complexes. Test acceptance will be recorded, and incentives will be paid for study visits, not for testing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-Community Health Worker-Family Partnership | Experimental | Behavioral: Nurse-Community-Family Partnership InterventionThe experimental arm will receive the Nurse-Community Health Worker-Family Partnership intervention |
| Standard of Care | No intervention | –The control arm will receive standard access to NYC Department of Health COVID-19 testing sites and standard COVID-19 public health messaging |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Residence in one of the public housing complexes in Mott Haven, South Bronx
- English or Spanish-speaking
- Age 10 years or older
- Willing and able to provide informed consent or assent
Key exclusion criteria (4 listed)
- Non-resident of one of the public housing complexes in Mott Haven, South Bronx
- Neither English nor Spanish speaker
- Younger than 10 years old, unless household index case tests antigen positive. In this instance, all members of family will be included.
- Unwilling or unable to provide informed consent or assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-Community-Family Partnership InterventionNurses conduct home visits on a monthly basis for the first five months post-baseline. During visits, nurses emphasize the importance of infection control measures and, jointly with household members, develop and follow-up on the implementation of an infection control plan tailored to the unique circumstances of the household. Nurses deliver training on infection control skills necessary for optimal implementation of the plan. Nurses offer at-home SARS-CoV-2 testing to all members of the household. Nurses conduct triage, medical case management, monitoring, and follow-up of individuals identified to have COVID-19 or any other acute health emergencies. CHWs conduct visits on a bi-weekly basis for the first five months post-baseline. CHWs deliver healthcare information and medical mistrust counseling in a culturally relevant and linguistically appropriate fashion; and provide social support, navigate household members to social welfare/vocational/economic/psychosocial services. | Behavioural | Nurse-Community Health Worker-Family Partnership |
Primary outcome
Household COVID-19 Testing Uptake
Time frame: Delayed Follow-Up (9 Months)
All medical services delivered by nurses during home-visits (such as COVID-19 test administration) will be carefully documented by the investigative team. At the time of the assessment, the investigators will obtain self-reported information regarding COVID-19 testing uptake by study participants in the treatment and control groups. Respondents will be asked whether they have received COVID-19 testing in the past three months [Yes/No].
COVID-19 Symptoms, Diagnoses, and Testing Scale
Time frame: Delayed Follow-Up (9 Months)
An adapted version of the (PhenX Toolkit) COVID-19 Symptoms, Diagnoses, and Testing Scale will be used to measure COVID-19 symptoms, diagnoses, and testing. Participants will be asked questions regarding whether they are currently sick with an illness that might be related to COVID-19, any symptoms the participant experienced in the past three months [Check All That Apply], and the result of the participant's last COVID-19 test [Positive/Negative].
10 secondary outcomes
COVID-19 Avoidant Behaviors Scale
Time frame: Delayed Follow-Up (9 Months)
Vaccine Uptake
Time frame: Delayed follow up (9 months)
COVID-19 Improved Household & Family Mutual Aid
Time frame: Delayed follow up (9 months)
COVID-19 Household Environment Scale
Time frame: Delayed follow up (9 months)
Household COVID-19 Testing Uptake
Time frame: Immediate follow up (6 months)
COVID-19 Symptoms, Diagnoses, and Testing Scale
Time frame: Immediate follow up (6 months)
COVID-19 Avoidant Behaviors Scale
Time frame: Immediate follow up (6 months)
Vaccine Uptake
Time frame: Immediate follow up (6 months)
COVID-19 Improved Household & Family Mutual Aid
Time frame: Immediate follow up (6 months)
COVID-19 Household Environment Scale
Time frame: Immediate follow up (6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Derived from this study: PubMed 41202466Guilamo-Ramos V, Benzekri A, Williams D, Thimm-Kaiser M, Wizentier MM, Goodman M, Amezquita-Castro B, Hagan H. A nurse-led clinical practice model to increase healthcare reach among underserved families during public health emergencies: A randomized controlled trial. Nurs Outlook. 2025 Nov-Dec;73(6):102591. doi: 10.1016/j.outlook.2025.102591. Epub 2025 Nov 6.
- Individual participant dataSharing planned: Yes. The project team will share all individual participant data that underlie the results reported in any future published manuscript, after deidentification (text, tables, figures, and appendices). We will make available the study protocol and statistical analysis plan. The project team will make the data available beginning 3 months and ending 5 years following article publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Investigators will be approved to conduct analyses to achieve the aims in the proposal that they submit for approval by an independent review committee. Proposals should be directed to Dr. Holly Hagan (hh50@nyu.edu). To gain access, data requesters will need to sign a data access agreement.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent M Guilamo-Ramos, PhD principal investigator
New York University
Holly Hagan, PhD principal investigator
New York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Community-Family Partnership Intervention in people with COVID-19, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Household COVID-19 Testing Uptake (time frame: Delayed Follow-Up (9 Months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04832919, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.